DEVICE FOR MATERIAL EXCHANGE AND METHOD FOR ITS MANUFACTURE

Description

[0001] The invention relates to a device for the exchange of substances between a first medium and a second medium comprising a housing element in which a hollow fiber package with material-permeable hollow fibers extending axially between the axial ends of the housing element is arranged, which are at least mutually encased with a potting compound at their respective axial end regions and which are permeable to flow around the first medium and through the second medium, wherein the housing element, in particular also the winding core, is closed at at least one of the axial ends, preferably at both axial ends, with a cover element.

[0002] The potting compound can be applied not only between the hollow fibers themselves, but preferably also between the inner wall of the housing element and the hollow fibers, and in particular between a winding core surrounded by the hollow fibers and the hollow fibers, if such a winding core is present. Such winding cores can serve, firstly, as a support element for the hollow fibers to be wound onto them, especially if the hollow fibers are wound around the winding core in the form of at least one mat, and secondly, also define the fluid flow, for example, if one of the fluids is guided through at least one channel in the winding core, particularly to guide it from the outside into the area around the hollow fibers or vice versa.

[0003] The cover element can have a media connection that is in fluid contact with the axially open ends of the hollow fibers. This allows the second medium to be supplied to or discharged from the hollow fibers via the cover element. Such a cover element is preferably arranged at both axial ends of the housing element and sealed to the edge regions of the fiber bundle and / or to the housing element.

[0004] Depending on the potting material used, edge leaks can occur, for example, if the potting material is not bonded tightly to the inner wall of the housing, as can be the case with silicone. A seal between the hollow fiber bundle / winding potted at the end and the housing and / or cover element can then typically be achieved using a sealing ring inserted into a groove in the end face of the housing element or the cover element.

[0005] In existing mass transfer devices, potting and sealing are therefore two separate processes, typically performed sequentially, making manufacturing complex. Furthermore, the annular groove itself can contain a leak bridging the sealing ring and can also form dead spaces where fluid can stagnate.

[0006] A housing element is preferably an axially extended tubular element, particularly with a circular free inner cross-section, but can in principle have any internal cross-sectional shape. The axial ends are preferably open and surrounded by annular end faces. The housing element can also have connections for introducing the first medium into and / or discharging it. Such connections can be provided, for example, at the axial end regions of the housing element.

[0007] Devices of this type are generally known in the prior art, e.g., as so-called oxygenators, in which a mass exchange takes place between blood as the first medium and a gas or gas mixture as the second medium, in particular to enrich blood with oxygen and remove carbon dioxide. The hollow fibers used in this case are semipermeable, i.e., not permeable to blood components, but permeable to gas, in particular oxygen and carbon dioxide.

[0008] Such devices are also known in other fields of application, e.g. as devices for carrying out dialysis.

[0009] The invention relates to devices of the type mentioned above, regardless of the specific application, but preferably to oxygenators.

[0010] The invention also relates to a manufacturing process for such devices. The manufacturing process itself is also known in principle in the prior art.

[0011] The device is manufactured by arranging a hollow fiber bundle with material-permeable hollow fibers extending between the axial ends of the housing element, particularly extending at least substantially axially, within a housing element of the device to be formed. Preferably, such a bundle is axially longer than the housing element, so that the axial ends of the hollow fiber bundle protrude from the housing element, preferably on both sides.

[0012] Such a hollow fiber bundle can be formed by winding hollow fibers, which are linked together with warp threads to form mats, for example onto a winding core. However, the hollow fiber bundle can also be created by laying or folding mats.

[0013] The package, if wound, can be inserted into the housing element together with the winding core, which in this case is surrounded by the hollow fiber package and preferably located at its center. In particular, in such a case, a fluid flow of one of the fluids, in the preferred application e.g. blood, can be provided through the winding core, for which – as already mentioned – the core can have at least one channel.

[0014] After the housing element is closed at at least one of its axial ends, preferably at both ends, with a potting cap, the hollow fibers are potted with a potting compound at their axial end region covered by the potting cap, at least with each other, preferably also with the inner wall of the housing element, and optionally also with a winding core. The potting cap typically has a pipe section extending axially from the cap surface, which surrounds the axial end region of the hollow fibers protruding from the housing element. The potting cap can preferably be substantially cup-shaped. The cap surface and pipe section can also form separate elements that are joined for the purpose of potting.

[0015] The potting process, also known as potting, is usually carried out in a centrifuge, whereby during centrifugation the potting compound is introduced into the housing element sealed with the potting lid, e.g. through connections in the potting lid.

[0016] According to the known state of the art, a polyurethane compound, for example, is used as a potting compound. This compound hardens and leads to the bonding of the hollow fibers to each other, to the inner wall of the housing element, and to the preferably used winding core. After hardening, such a polyurethane compound exhibits virtually no elasticity that would allow reversible deformation.

[0017] After potting and hardening of the potting compound, the potting cap is removed, and the potted hollow fibers are opened at their axial ends, which are either encased in the potting compound or previously sealed. This is done, for example, by cutting or sawing in a plane perpendicular to the axial longitudinal direction of the hollow fibers. The housing element, containing the potted and opened hollow fibers, is then tightly sealed with a lid element, as described above.

[0018] Preferably, a cured state is understood to be one in which the hardening of the casting compound is complete and no longer progresses. A hardened state can be one in which the casting compound has hardened compared to its previous state at the time of casting, but in particular, the hardening process need not yet be complete, and in particular, it may be complete.

[0019] The aforementioned features, in particular apart from the polyurethane potting compound, may preferably also occur in the invention.

[0020] Against this background, with the problems of the existing type of seal, it is an object of the invention to provide a device of the type mentioned above and a manufacturing method of the type mentioned above, which enables a simple and reliable creation of a seal between the end face of the housing element and the cover element and preferably also between the housing element and the hollow fiber package.

[0021] This problem is solved according to the invention by a manufacturing process in which, simultaneously with the potting of the hollow fibers, an outer sealing ring is created from the potting compound itself, radially surrounding the hollow fiber package, and in particular circumferentially surrounding the longitudinal axis of the hollow fiber package over a full 360 degrees, by the potting compound flowing into an annular gap formed between the end faces of the housing element and the potting cap. Preferably, this annular gap extends circumferentially over a full 360 degrees in the inner wall of the overall housing formed from the housing element and the potting cap.

[0022] The annular gap in the overall housing is therefore open in one direction radially inwards, so that potting compound from the interior of the overall housing can penetrate into this annular gap.

[0023] Preferably, it can be provided that not only an outer sealing ring is created from the potting compound, but also an inner sealing ring. This is particularly relevant in embodiments where the hollow fiber bundle is supported as a coil on a core that remains within the housing. In this case, there is not only an annular gap, in this case an outer annular gap, but also an inner annular gap. In such coiled hollow fiber bundles, the bundles are preferably ring-shaped in cross-section perpendicular to their longitudinal extent. In particular, this cross-sectional shape also applies to the potting compound after its hardening or curing.

[0024] For packages without a winding core, such a design with an inner sealing ring is preferably not provided. In such a design, the hollow fiber package is preferably cylindrical in cross-section perpendicular to its longitudinal extent, and more preferably the cross-section is completely filled with hollow fibers.

[0025] The process may include the creation of an inner sealing ring from the potting compound simultaneously with the potting of the hollow fibers against each other on the inner circumference of the hollow fiber package by the potting compound flowing into an annular gap formed between the end faces of a winding core that carries the hollow fiber package and a cover element in the potting lid, which is then to be referred to as the inner annular gap.

[0026] The outer and / or inner sealing ring is formed directly from the casting compound after it has been poured and hardened or cured.

[0027] The housing element and the potting cap preferably abut each other at a parting line in all possible configurations, making contact at this parting line. The same applies, if a winding core is provided, to the core and a plug in the cap element.

[0028] In one possible embodiment, it can be provided that at least the outer annular gap, preferably the outer and the inner annular gap, borders the parting plane in the axial direction, in particular that it is arranged only in one of the two elements and extends axially towards the other element up to the parting plane.

[0029] InIn another possible embodiment, at least the outer annular gap, and preferably also the inner annular gap, can lie in the axial direction around the parting plane; in particular, the outer annular gap is then partially arranged in the housing element and in the potting cap, and the inner annular gap is partially arranged in the winding core and plug.

[0030] A device of the type mentioned above can be manufactured in which, according to the invention, an outer sealing ring surrounding the hollow fiber package is formed on at least one of the axial ends of the housing element, preferably on both, from the potting compound arranged between the hollow fibers, and extends radially at least partially between the axial end faces of the housing element and the cover element and is compressed between them.

[0031] InIn the preferred embodiment, at least one of the axial ends of the winding core carrying the hollow fibers, preferably both, can also have an inner sealing ring formed from the potting compound arranged between the hollow fibers, which extends in a radial direction at least partially between the axial end faces of the winding core and a plug in the cover element and is compressed between them.

[0032] The cover element, as already described for the potting cap, can preferably be essentially pot-shaped, comprising a cover surface and an axially extending tube section, which are integrally formed. The cover surface and tube section can also form separate elements that are joined to create the entire device housing. The tube section can surround an axial end region of the potted hollow fibers. The cover surface lies axially adjacent to this end region of the hollow fibers, particularly at a distance.

[0033] The partial extension is preferably understood to mean that, viewed radially, the outer sealing ring extends radially outwards from the radial inner edge of the end faces, but does not completely cover the respective end face in the radial direction. Preferably, the outer sealing ring is therefore not accessible from the outside in the finished device, but rather enclosed between the end faces of both elements. However, an embodiment is also possible in which the sealing ring completely covers the end faces of both elements or even projects beyond them in the radial direction.

[0034] An end face of the housing element and / or cover element and / or potting cap and / or winding core and / or plug or cover element is preferably understood to be the respective end face, in particular annular surface at the axial end region of the element in question, which at least partially fulfills a sealing purpose between the opposing elements. Such sealing end faces are thus axially opposed to each other, in particular they contact each other directly at least partially and indirectly via the respective sealing ring. Other elements / surface elements may also be arranged at the axial end of an element, e.g., for the purpose of fastening, e.g., by screwing, snapping, etc.

[0035] Preferably, such an outer sealing ring according to the invention is formed after potting by such areas of the potting compound which lie radially outside an (imaginary) envelope surrounding the hollow fiber package, in particular at least by such areas which are arranged radially outside the inner wall of the housing element and / or cover element and / or potting cover.

[0036] In a preferably provided inner sealing ring, this is formed after potting by such areas of the potting compound which lie radially within an (imaginary) envelope adjacent to the inner hollow fiber package circumference, in particular at least by such areas which are arranged radially inside the outer wall of the winding core and / or plug and / or cover element of a potting lid.

[0037] This embodiment according to the invention already has the advantage that the potting compound completely fills at least the outer annular gap, and preferably also the inner annular gap, so that each ring area in the housing element or winding core, which receives the sealing ring, is completely filled with the sealing ring without any voids. Stagnation areas can thus be prevented.

[0038] Preferably, the casting compound may be formed by a liquid or pasty, in particular at least flowable, applicable hardening elastomer with a hardness, in particular in the hardened or cured state, of less than Shore A 100, preferably less than Shore A 60, more preferably less than Shore A 30.

[0039] This allows for reversible elasticity of the formed outer and / or inner sealing ring, as is known from conventional sealing rings. Thus, in addition to encapsulating the hollow fibers themselves, the potting compound can also provide the necessary sealing properties particularly well, especially in contrast to conventional polyurethane.

[0040] It is particularly preferred to use a silicone / silicone rubber as a potting compound, especially one that can be applied in liquid form in a centrifuge and then hardens / cures, for example, by cross-linking. Latex can also be used as a potting compound.

[0041] The outer annular gap to be filled with the potting compound is preferably defined by a recess in the end face of the housing element and / or the potting cap, open axially and radially inwards. A recess can therefore be provided in the end face of only one of the two elements or in both. The preferably provided inner annular gap to be filled is defined, for example, by a recess in the end face of the winding core and / or the cover element in the potting cap, open axially and radially outwards. Similarly, for the inner annular gap, a recess can be provided in the end face of only one of the two elements or in both.

[0042] Depending on the shape of the annular gap between the housing element and the potting cap or the winding core and the cover element, different geometries of the respective sealing ring and thus different possible sealing options can result.

[0043] At least during the final stages of casting and hardening or curing of the potting compound, the resulting outer and / or inner sealing ring is integrally or materially bonded to the potting compound in the areas between the axial ends of the cast hollow fibers. Preferably, it remains this way in the finished material transfer device, but this is not absolutely necessary.

[0044] In one possible embodiment, the process may provide that when the hollow fiber ends are opened, in particular by separating glued hollow fiber ends or by separating factory-sealed hollow fiber ends, the outer and / or inner sealing ring is also separated from the glued hollow fiber package.

[0045] This can occur, for example, if the sealing ring is manufactured in a configuration where, after removal of the potting cap and / or cover element, it has a region at its radially outer end that is directed axially back from the annular gap opening towards the housing element and / or a region at its radially inner end that is directed axially back towards the winding core, and with this region resting in a recess, e.g., annular groove, in the end face of the housing element and / or winding core that is open at least in the axial direction. At the time of potting, this annular groove in the housing element or winding core represents an undercut area of ​​the respective annular gap.

[0046] The separation of the closed hollow fiber ends can be carried out, for example, flush with the end face of the housing element and / or winding core, whereby the formed outer and / or inner sealing ring remains in the recess / annular groove filling the cavity and is separated from the hollow fiber package.

[0047] By placing the cover element and / or plug, the resulting outer and / or inner sealing ring between the end faces of the cover element and housing element, or between the plug and the winding core, can be compressed, for example, by means of an annular projection extending from the cover element to the housing element or from the plug to the winding core, which is positioned opposite the recess / annular groove. In particular, the plug, preferably if it is separate from the cover element, can be attached to the winding core, for example, by snapping, screwing, or the like.

[0048] In contrast, a preferred embodiment provides that after opening the hollow fiber ends, in particular by cutting off encapsulated hollow fiber ends or by separating factory-sealed hollow fiber ends, the outer and / or inner sealing ring remains bonded / integrally attached to the glued hollow fiber package and is compressed by placing the cover element between the end faces of the cover element and the housing element and / or by placing the plug between the end faces of the plug and the winding core.

[0049] In particular, it is intended to separate the closed hollow fiber ends in a plane that is spaced apart, in particular at least by the desired thickness of the sealing ring, from the distal end face plane, in particular from the axially outermost end face plane of the housing element and / or winding core.

[0050] Preferably, the parting plane is spaced away from the distal end face plane of the housing element and / or winding core by a distance that is at least 20% greater than the desired axial thickness of the formed sealing ring, more preferably at least 40% greater than the desired axial thickness of the formed sealing ring, particularly in its radially inner area.

[0051] This design allows the outer and / or inner sealing ring to be integrally bonded to the potting compound between the hollow fibers in the finished device for mass transfer. This permanent bond to the potted hollow fiber bundle offers the advantage that the outer sealing ring simultaneously seals the outer surface of the hollow fiber bundle against both the housing and the lid elements. Furthermore, if an inner sealing ring is present, placing the plug onto the winding core also simultaneously seals the inner surface of the hollow fiber bundle against the lid element.

[0052] The shape of the annular gap defined between the potting cap and the housing element and / or between the cover element in the potting cap and the winding core can, for example, form an outer sealing ring which, after removal of the potting cap, lies in a recess arranged radially inside the end face of the housing element, and / or form an inner sealing ring which, after removal of the potting cap and cover element, lies in a recess arranged radially outside the end face of the winding core.

[0053] The outer sealing ring can, for example, be flush with the distal end face of the housing element, but preferably also project axially beyond the end face area surrounding the recess, in particular the distal end face of the housing element. The inner sealing ring can, for example, be flush with the distal end face of the winding core, but preferably also project axially beyond the end face area located radially inside the recess, in particular the distal end face of the winding core. This allows for particularly simple compression of the sealing ring by placing the cover element and / or the plug on top, especially with the compression occurring into the respective recess.

[0054] With regard to the outer sealing ring, the cover element can achieve compression, for example, with an axial end face formed entirely in one plane, particularly a stepless one, or by means of an axial, preferably annular, projection arranged on the end face of the cover element, preferably radially inward, which engages partially in the recess. With regard to the inner sealing ring, the plug can achieve compression, for example, with an axial end face formed entirely in one plane, particularly a stepless one, or by means of an axial, preferably annular, projection arranged on the end face of the plug, preferably radially outward, which engages partially in the recess.

[0055] Likewise, the formed outer sealing ring can rest on a flat surface area of ​​the end face of the housing element at a predetermined height in only a single end face plane, in particular on a flat surface area of ​​the end face of the housing element which is formed without a recess in its radial extent, and can be compressed by placing the cover element in an axially and radially inwardly open recess in the end face of the cover element with a depth less than the predetermined height.

[0056] A preferably formed inner sealing ring can rest on a flat surface area of ​​the end face of the winding core at a predetermined height in only a single end face plane, in particular on a flat surface area formed without a recess in the radial extent, and be compressed by placing the plug in an axially and radially outwardly open recess in the end face of the plug with a depth less than the predetermined height.

[0057] In general, with regard to the outer sealing ring of the device, an axial, preferably annular, projection can be arranged radially inside one of the axial end faces of the housing element or cover element, which at least partially engages in the axially open recess in the end face of the opposing element. Furthermore, with regard to the inner sealing ring of the device, an axial, preferably annular, projection can be arranged radially outside one of the axial end faces of the winding core or plug, which at least partially engages in the axially open recess in the end face of the opposing element.

[0058] Likewise, the end face of the cover element or the plug can have a recess that overlaps the protruding sealing ring, preferably having a depth that is less than the protrusion to ensure compression.

[0059] In The finished device can generally be designed with regard to the outer sealing ring such that the axial end face of the housing element and / or the cover element has a recess open axially and radially inwards, in which the outer sealing ring is compressed. In With regard to the optional inner sealing ring, the finished device may generally be designed so that the axial end face of the winding core and / or the plug has an axially and radially outwardly open recess in which the inner sealing ring is compressed.

[0060] Insofar as recesses and / or projections on the end faces of elements, e.g. of cover element and / or housing element and / or potting cap and / or cover element and / or plug, are described in the explanatory notes, it is preferably understood that these extend circumferentially around the longitudinal axis of the hollow fiber package over a full 360 degrees, and are therefore formed in a ring shape.

[0061] Another possible embodiment may provide that the outer sealing ring extends radially outwards over and beyond a projection, preferably a radially inner projection, on one of the end faces of the housing element (preferred) or cover element, and is axially bent through a stepped area at the recess of the opposite element into an area that is arranged radially outside the projection, preferably also axially recessed behind the projection.

[0062] A possible analogous embodiment may provide that the preferably existing inner sealing ring extends radially inwards over and beyond a projection, preferably a radially outer projection on one of the end faces of the winding core (preferred) or plug, and is axially bent through a stepped area at the recess of the opposite element into an area that is arranged radially inside the projection, preferably also axially recessed behind the projection.

[0063] In the process, the outer sealing ring can be formed, for example, in such a way that it covers a radially internal axial projection in the end face of the housing element and projects outwards in a radial direction, and is compressed and bent in an axial direction by a recess in the end face of the cover element that encompasses the projection when the cover element is placed on top.

[0064] Similarly, the optional inner sealing ring can be formed, for example, in such a way that it covers a radially external axial projection in the end face of the winding core and projects inwards in a radial direction, and is compressed and bent in an axial direction by a recess in the end face of the plug that encompasses the projection when the plug is placed on top.

[0065] Preferred embodiments are explained with reference to the figures.

[0066] Figur 1Figure 1 shows a first step of the manufacturing process, in which a hollow fiber bundle 2 is inserted into the housing element 1, projecting axially beyond the parting line TE between the housing element 1 and the potting cap 3, or beyond the distal end face SE of the housing element 1. The potting cap 3 axially closes the housing element 1, and the hollow fiber bundle 2 is enclosed at its end by a tubular section 3a of the potting cap 3.

[0067] The hollow fiber bundle is formed, for example, by a winding of hollow fibers, which are connected, for example, to at least one mat with warp threads, wherein the winding is supported on a winding core 2a, which can also remain in the housing element 1. A cover element 3b is arranged on the potting cap 3, which is axially opposite the winding core 2a, in particular covering its axial end face. The cover element 3b can be formed integrally with the potting cap 3 or be separate from it. For example, if separate, it can be clamped between the potting cap 3 and the winding core 2a.

[0068] Both annular end faces of housing element 1 and potting cap 3 have radially inward recesses 1.1 and 3.1, respectively, which are open axially and radially inward, thus forming an annular gap on the inner wall of the closed assembly, i.e., the overall housing. In this embodiment, the annular gap 1.1, 3.1 lies axially around the parting plane TE of both elements 1, 3, which coincides with the distal end face plane SE of housing element 1. The distal end face of the housing element preferably lies in the same plane as the distal end face of the winding core 2a.

[0069] In addition to the outer annular gap thus formed, which extends radially around the hollow fibers and is at least provided for in the invention, this embodiment further provides that an inner annular gap also extends radially inward to the hollow fiber bundle 2. This inner annular gap is formed between the winding core 2a and the cover element 3b. For this purpose, the cover element 3b and the winding core 2a each have radially outwardly located recesses 3b.1 and 2a.1, respectively, which are open axially and radially outward. The inner annular gap 2a.1, 3b.1 also lies axially around the parting plane TE.

[0070] Figure 2The same arrangement is shown after the axial end potting. The potting compound 4 has covered the hollow fiber ends, possibly sealing them if they were not closed by the manufacturer, and has also penetrated the outer annular gap formed by the recesses 1.1 and 3.1, as well as the inner annular gap formed by the recesses 3b.1 and 2a.1, thus forming an outer sealing ring 5a that surrounds the hollow fiber package 2 on the outside and an inner sealing ring 5b that is arranged inside along the inner circumference of the hollow fiber package 2.

[0071] Figur 3a shows the arrangement after removal of the potting cap 3 and also of the cover element 3b. Figur 3bThe same arrangement is shown after part of the encapsulated hollow fibers have been separated to open them. The separation takes place in the separation plane AE at a distance from the sealing rings 5a / 5b that, in this embodiment, extends beyond the distal end face SE of the housing element 1.

[0072] Figure 4 Figure 1 shows the situation after the cover element 6 of the device has been placed on it. The cover element 6 is, in particular similar to the potting cap 3, pot-shaped and has a cover surface, preferably an outwardly convex cover surface 6a, from which a tubular section 6b extends axially in the direction of the housing element 1, which surrounds the potted hollow fiber ends in some areas.

[0073] The cover element 6 also has a connection 6.3 for supplying gas to or from the open hollow fibers. Here, the cover element 6 has no recess in the end-face area that interacts with the distal end face 1.2 of the housing element 1 for sealing purposes, and compresses the outer sealing ring 5a by placing its end face onto the axially projecting area of ​​the outer sealing ring 5a.

[0074] The inner sealing ring 5b is compressed by a plug 6c, which may be an integral part of the cover element 6 or may be designed separately. The plug 6c rests in contact with the winding core 2a. In particular, the plug 6c, preferably if it is separate from the cover element 6, may be attached to the winding core 2a, e.g., by snapping, screwing, or the like. This can also apply to all possible embodiments, including those not shown.

[0075] Figur 5ashows an alternative in which the front surface of the housing element 1 lies in a single plane, i.e., it has no recess. In The end face of the winding core 2a, which is also continuously flat, lies on the same plane and likewise has no recess. An axially and radially inwardly open recess 3.1 is located only in the end face of the potting cap 3 to form the outer annular groove, and an axially and radially outwardly open recess 3b.1 is located only in the cover element 3b to form the inner annular groove.

[0076] In the finished device according to the Figur 5bThe outer sealing ring 5a is only inserted into a radially inwardly and axially open recess 6.1 and is compressed by it, since the depth of the recess 6.1 is less than the height of the sealing ring 5a above the end face of the housing element 1. The inner sealing ring 5b is only inserted into a radially outwardly and axially open recess 6c.1 and is compressed by it, since the depth of the recess 6c.1 in the plug 6c is less than the height of the sealing ring 5b above the end face of the winding core 2a.

[0077] Figur 6a Figure 1 shows an embodiment in which only one radially inwardly and axially open recess 1.1 is arranged in the housing element 1. The axial end face of the potting cap 3 lies in a single plane (without a recess) and covers the recess 1.1 in the stepped end face of the housing element 1.

[0078] The according to Figur 6bThe outer sealing ring 5a thus lies in the distal end-face plane SE of the housing element 1 and does not project beyond the recess 1.1. For compression, the cover element 6 now has an axially annular projection 6.2 on its end face, radially inward and directed towards the housing element 1, which partially engages in the recess 1.1 on the end face of the housing element 1, which is filled with the sealing ring 5a.

[0079] With regard to the inner sealing ring 5b, it is also located in the distal end-face plane SE of the housing element 1 or the winding core 2b and does not project beyond the recess 2b.1. For compression, the plug 6c has an axial annular projection 6c.2 on its end face, radially outward and directed towards the winding core 2a, which partially engages in the recess 2a.1 on the end face of the winding core 2a, which is filled by the sealing ring 5b.

[0080] The Figuren 7a and 7bshow an embodiment in which the fully formed outer sealing ring 5a is in the finished device ( Figur 7b ) a radially internal projection 1.2 in the housing element 1 and also projects radially outwards beyond it in a radially outward direction. The projecting part of the sealing ring 5a is bent and compressed in the axial direction by a step 6.1.a of the axially and radially inwardly open recess 6.1 in the end face of the cover element 6.1. The step 6.1.a radially outwards limits the recess 6.1.

[0081] The inner sealing ring 5b is fitted in the finished device ( Figur 7b) a radially outward projection 2a.2 in the winding core 2a and also projects radially inward beyond it in a radially inward direction. The projecting part of the sealing ring 5b is bent and compressed in the axial direction by a step in the axially and radially outwardly open recess 6c.1 in the end face of the plug 6c. The step limits the radial inward boundary of the recess 6c.1.

[0082] In Figur 7aIt is evident that an outer sealing direction 5a projecting beyond the projection 1.2 can be created during potting by filling the radially outwardly recessed area radially behind the projection 1.2, e.g., with a filling ring 7a, which is removed again before the cover element 6 is fitted. The filling ring 7a creates a radially outwardly axially supported area of ​​the annular gap 3.1, so that a radially straight outer sealing ring 5a can be produced that projects radially outward beyond the projection 1.2. After removing the filling ring 7a, the outer sealing ring 5a can be bent by the cover element 6 into the area filled by the filling ring 7a during potting.

[0083] Furthermore, an inner sealing ring 5b projecting beyond the projection 2a.2 can be produced. During casting, this is achieved by filling the radially internally recessed area behind the projection 2a.2, for example, with a filler ring 7b, which is removed again before the plug 6c is fitted. The filler ring 7b creates a radially internal, axially supported area of ​​the annular gap 3b.1, so that a radially straight inner sealing ring 5b can be produced that projects radially inwards beyond the projection 2a.2. After removing the filler ring 7b during casting, the inner sealing ring 5b can be bent by the plug 6c into the area filled by the filler ring 7b.

Claims

1. Device for substance exchange between a first medium, in particular blood, and a second medium, in particular a gas / gas mixture, comprising a housing element (1) in which there is arranged a hollow-fibre bundle (2) containing substance-permeable hollow fibres, which extend axially between the axial ends of the housing element (1), are wound on a winding core and at their respective axial end region are potted with a potting compound (4), at least among one another, and around which the first medium can flow and through which the second medium can flow, wherein the housing element (1), at at least one of the axial ends, preferably at both axial ends, is closed by a cover element (6), in particular one which has a media connection (6.1) in fluidic communication with the axially open hollow-fibre ends, characterized in that, at at least one of the axial ends of the housing element (1), preferably at both ends, an outer sealing ring (5a) surrounding the hollow-fibre bundle (2) is formed from the potting compound (4) arranged between the hollow fibres, which outer sealing ring extends in the radial direction at least in part between the axial end faces of the housing element (1) and of the cover element (6) and is compressed between these, and at at least one of the axial ends of the winding core (2a) which carries the hollow fibres (2), preferably at both ends, an inner sealing ring (5b) arranged on the inner circumference of the hollow-fibre bundle (2) is formed from the potting compound (4) arranged between the hollow fibres, which inner sealing ring extends in the radial direction at least in part between the axial end faces of the winding core (2a) and of a plug (6c) in the cover element (6) and is compressed between these.

2. Device according to Claim 1, characterized in that the outer and / or inner sealing ring (5a, 5b) is in one piece with / cohesively bonded to the potting compound (4) between the hollow fibres.

3. Device according to one of the preceding claims, characterized in that the potting compound (4) is formed by an elastomer, preferably with a hardness of less than Shore A 100, preferably less than Shore A 60, more preferably less than Shore A 30, in particular with the potting compound (4) being formed from a silicone / silicone rubber.

4. Device according to one of the preceding claims, characterized in that the axial end face of the housing element (1) and / or of the cover element (6) has, radially inwardly, an axially and radially inwardly open recess (1.1, 6.1), in which the outer sealing ring (5a) lies compressed, and / or the axial end face of the winding core (2a) and / or of the plug (6c) in the cover element (6) has, radially outwardly, an axially and radially outwardly open recess (1.1, 6.1), in which the inner sealing ring (5b) lies compressed.

5. Device according to Claim 4, characterized in that an axial, preferably annular, projection (6.2, 1.2) is arranged radially inwardly on one of the end faces of the housing element (1) or cover element (6) and lies at least in part in the axially open recess (1.1 , 6.1) in the end face of the opposite element (1, 6), or an axial, preferably annular, projection (6c.2, 2a.2) is arranged radially outwardly on one of the end faces of the winding core (2a) or of the plug (6c) in the cover element (6) and lies at least in part in the axially open recess (2a.1, 6c.1) in the end face of the opposite element (6c, 2a).

6. Device according to Claim 5, characterized in that the outer sealing ring (5a) is extended in the radial direction outwardly beyond the projection (1.2) and overhangs it and, by a stepped region (6.1.a) at the recess (6.1) of the opposite element (6), is bent axially into a region which is arranged set back radially outwardly from the projection (1.2), in particular also axially behind the projection (1.2), and / or the inner sealing ring (5b) is extended in the radial direction inwardly beyond the projection (2a.2) and overhangs it and, by a stepped region at the recess (6c.1) of the opposite element (6c), is bent axially into a region which is arranged set back radially inwardly from the projection (2a.2), in particular also axially behind the projection (2a.2).

7. Method for production of a device for substance exchange between a first medium, in particular blood, and a second medium, in particular a gas / gas mixture, preferably for production of a device according to one of the preceding claims, wherein a hollow-fibre bundle (2) surrounding a winding core (2a), with substance-permeable hollow fibres extending between the axial ends of the housing element (1), is arranged in a housing element (1) of the device, which hollow fibres, after closure of the housing element (1) at at least one of its axial ends, preferably at both ends, are potted with a potting compound (4), at least among one another, with a potting cover (3) at their axial end region covered by the potting cover (3), in particular in a centrifuge, and, after the potting, the potting cover (3) is removed, the potted hollow fibres are opened at their axial ends, and the housing element (1) is tightly sealed with a cover element (6), characterized in that, simultaneously with the potting of the hollow fibres among one another, a sealing ring (5a) surrounding the hollow-fibre bundle (2) radially on the outside is created from the potting compound (4), by the potting compound (4) flowing into an annular gap (1.1, 3.1) formed between the end faces of housing element (1) and potting cover (3), in particular an outer annular gap (1.1, 3.1), and, simultaneously with the potting of the hollow fibres among one another at the inner circumference of the hollow-fibre bundle (2), an inner sealing ring (5b) is created from the potting compound (4), by the potting compound (4) flowing into an annular gap (2a.1, 3b.1), in particular an inner annular gap (2a.1, 3b.1), formed between the end faces of the winding core (2a), which carries the hollow-fibre bundle (2), and a cover element (3b) in the potting cover (3) covering the winding core (2a).

8. Method according to Claim 7, characterized in that the annular gap (1.1, 3.1), in particular the outer annular gap (1.1, 3.1), is defined by an axially and radially inwardly open recess (1.1, 3.1) in the end face of the housing element (1) and / or of the potting cover (3), and / or the annular gap (2a.1, 3b.1), in particular the inner annular gap (2a.1, 3b.1), is defined by an axially and radially outwardly open recess (2a.1, 3b.1) in the end face of the winding core (2a) and / or of the cover element (3b) in the potting cover (3).

9. Method according to either of preceding Claims 7 and 8, characterized in that, with the opening of the hollow-fibre ends, in particular by cutting off potted hollow-fibre ends or also by separating hollow-fibre ends closed by the manufacturer, the outer sealing ring (5a) and / or the inner sealing ring (5b) is also separated from the bonded hollow-fibre bundle (2), in particular the outer sealing ring (5a) remains in a recess, open at least in the axial direction, in the end face of the housing element (1), and, by placement of the cover element (6), is compressed between the end faces of cover element (6) and housing element (1), and / or the inner sealing ring (5b) remains in a recess, open at least in the axial direction, in the end face of the winding core (2a), and, by placement of the plug (6c), is compressed between the end faces of plug (6c) and winding core (2a).

10. Method according to either of preceding Claims 7 and 8, characterized in that, after the opening of the hollow-fibre ends, in particular by cutting off potted hollow fibre ends or also by separating hollow-fibre ends closed by the manufacturer, the outer sealing ring (5a) and / or the inner sealing ring (5b) remains attached to the hollow-fibre bundle (2) by cohesive bonding / integral connection, in particular the outer sealing ring (5a), by placement of the cover element (6), is compressed between the end faces of cover element (6) and housing element (1), and / or the inner sealing ring (5b), by placement of the plug (6c), is compressed between the end faces of plug (6c) and winding core (2a).

11. Method according to one of preceding Claims 7 to 10, characterized in that the shape of the annular gap (1.1, 3.1) defined between potting cover (3) and housing element (1) forms an outer sealing ring (5a) which, after removal of the potting cover (3), a. lies in a recess (1.1) arranged radially inwardly in the end face of the housing element (1), preferably protruding in the axial direction beyond the end face region of the housing element (1) surrounding the recess (1.1), and, by placement of the cover element (6), is compressed into the recess (1.1), in particular by an axial projection (6.2) arranged radially inwardly on the end face of the cover element (6), or b. rests at a predetermined height on a planar surface region of the end face of the housing element (1) that is formed in the radial extent without a recess and, by placement of the cover element (6), is compressed in an axially and radially inwardly open recess (6.1) in the end face of the cover element (6), to a depth less than the predetermined height, or c. covers a radially inner axial projection (1.2) in the end face of the housing element (1) and protrudes outward in the radial direction and, upon placement of the cover element (6), is compressed by a recess (6.1) surrounding the projection (1.2) in the end face of the cover element (6) and bent in the axial direction.

12. Method according to one of preceding Claims 7 to 11, characterized in that the shape of the annular gap (2a.1, 3b.1) defined between the cover element (3b) in the potting cover (3) and the winding core (2a) forms an inner sealing ring (5b) which, after removal of the cover element (3b) and of the potting cover (3), a. lies in a recess (2a.1) arranged radially outwardly in the end face of the winding core (2a), preferably protruding in the axial direction beyond the end face region of the winding core (2a) lying radially inward from the recess (2a.1), and, by placement of the plug (6c), is compressed into the recess (2a.1), in particular by an axial projection (6c.2) arranged radially outwardly on the end face of the plug (6c), or b. rests at a predetermined height on a planar surface region of the end face of the winding core (2a) that is formed in the radial extent without a recess and, by placement of the plug (6c), is compressed in an axially and radially outwardly open recess (6c.1) in the end face of the plug (6c), to a depth less than the predetermined height, or c. covers a radially outer axial projection (2a.2) in the end face of the winding core (2a) and protrudes inward in the radial direction and, upon placement of the plug (6c), is compressed by a recess (6c.1) surrounding the projection in the end face of the plug (6c) and bent in the axial direction.